CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
oligofructose-enriched inulin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00335504
NCT00335504Phase 2Completed

Randomized, Phase II Trial of Atorvastatin, RAFTILOSE Synergy 1, and Sulindac Among Patients at Increased Risk for Sporadic Colorectal Neoplasia

National Cancer Institute (NCI)·interventional·Posted Jun 12, 2006·Updated Feb 15, 2017

In Brief

A Phase 2 clinical trial evaluating oligofructose-enriched inulin, sulindac, and 3 other interventions for Colon Cancer and 2 related conditions. Completed, enrolled 85 participants across 1 site.

Detailed Summary

This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia. Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of atorvastatin calcium, oligofructose-enriched inulin, or sulindac may stop cancer from forming in patients at increased risk of colorectal neoplasia. It is not yet known whether atorvastatin calcium, oligofructose-enriched inulin, or sulindac are more effective than a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2006
Enrollment StartMar 1, 2006
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.1 years ago

Interventions

oligofructose-enriched inulindrug

Given orally

sulindacdrug

Given orally

placebodrug

Given orally

atorvastatin calciumdrug

Given orally

laboratory biomarker analysisother

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